- Dana-Farber Cancer Institute (Boston, MA)
- …every stage. This requires: 1. Screening SRC agenda for clinical trials involving human gene therapy or infectious agent that proposals require IBC review, in ... the event that the study team did not correctly answer question 11.2, which routes the trial to biosafety. Reporting errors to OHRS and Study Team. 2. Assigns scientific reviewers of clinical trials, obtains additional information from sponsors as required by… more
- Sanofi Group (Cambridge, MA)
- …Sanofi and with a scope that includes small molecule, monoclonal antibody, peptide, gene therapy including nucleic acid modalities. The individual in this ... position is an integral part of the therapeutic area project teams and cross-functional Translational Medicine Subteam from preclinical development through post-marketing. A key focus of this role is the path from the research phase through early clinical… more
- ThermoFisher Scientific (Plainville, MA)
- …Thermo Fisher Scientific's Viral Vector Services (VVS) is a rapidly growing, gene therapy contract development and manufacturing organization (CDMO) that is ... seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. **How will you make an impact?**… more
- Takeda Pharmaceuticals (Boston, MA)
- …of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science. + Strong oral and written ... communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability. + Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs… more
- ThermoFisher Scientific (Boston, MA)
- …drug development settings. + Understanding of process development for cell and gene therapy products. + Team player, innovative, collaborative, and initiative. ... **Working Environment:** Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and… more
- ThermoFisher Scientific (Boston, MA)
- …and Abilities:** + Experience in analytical CMC development for cell and gene therapy or biologics, particularly from late-stage development through ... commercialization. + Demonstrated experience in SOP and technical report writing, especially validation and technical transfer, regulatory documents, (eg BLA and RoW submission) is highly desired. + Strong technical writing skills are essential; regulatory… more
- ThermoFisher Scientific (Cambridge, MA)
- …to the pharmaceutical and biological industries is preferred. Knowledge of gene therapy product and/or process development preferred. Excellent problem ... solving and critical thinking skills, including strong attention to detail. Advise supervisor of factors that may affect quality, accuracy, timeliness, and usefulness of data. Excellent organization, planning, and time management skills. Self-motivated,… more
- ThermoFisher Scientific (Plainville, MA)
- …Information** Thermo Fisher Scientific, Viral Vector Services (VVS) is a dynamic gene and cell therapy contract development and manufacturing organization that ... an impact?** Thermo Fisher Scientific, VVS division, is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for… more
- ThermoFisher Scientific (Boston, MA)
- …with internal and external functions, including contract testing organizations + Experience in gene and/or cell therapy and/or CRISPR gene editing + ... Experience with analytical support for late-stage or commercial biological products and cGMP manufacturing + Experience with critical reagent management + Experience of using JMP or similar statistical tools is a plus + Ability to prioritize objectives from… more
- Actalent (Boston, MA)
- …+ Eight years of relevant Quality experience in the biotech industry, preferably with gene or cell therapy experience in an early-phase organization. + Strong ... understanding of GxP Quality and expertise in Quality Management System development and execution. + Experience managing Quality Systems for external manufacturing. + Knowledge of Biologics manufacturing sciences and processes at clinical and commercial… more